Quality by design (QbD) approach and application of preformulation studies for a poorly water soluble model drug, Nimesulid
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Tarih
2023
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
Formulating poorly water-soluble medications is one of the most crucial challenges encountered in the pharmaceutical industry. Due to this obstacle, the model drug chosen for this research was Nimesulide. The primary goal of this research was to obtain information on the drug's physical and chemical properties, either alone or in combination with excipients, in order design a formulation and create a stable and bioavailable dosage form. Formulations were designed using Flowlac (R) 100 and Avicel (R) 102 as fillers, Kollidon (R) 30 as a binder, Magnesium stearate as a lubricant, and variable concentrations of Kollidon (R) CL and Primojel as superdisintegrants. The tableting process was conducted using a compaction simulator. The Quality by Design (QbD) approach allows formulators to enhance product development with built-in product quality. In this study, to understand the relationship between excipients and compaction force differences on tablet properties, the QbD approach was applied by using a compaction simulator.
Açıklama
Anahtar Kelimeler
Compaction Simulator Nimesulide, Quality by Design
Kaynak
Acta Farmaceutica Bonaerense
WoS Q Değeri
N/A
Scopus Q Değeri
N/A
Cilt
42
Sayı
1
Künye
Özalp, Y., Khamis, H., Jiwa, N., Mesut, B., Aksu, N. (2023). Quality by design (QbD) approach and application of preformulation studies for a poorly water soluble model drug, Nimesulid. Acta Farmaceutica Bonaerense, 42(1), 142-149.
